Duns Number:001307735
Device Description: Amine 75cm2 Rectangular Canted Neck Cell Culture Flask with Vented Cap
Catalog Number
356726
Brand Name
Corning® PureCoat™
Version/Model Number
356726
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KJA
Product Code Name
Flask, tissue culture
Public Device Record Key
8cee6a24-4e73-492c-b473-b80a8254e180
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2019
Package DI Number
50389151000226
Quantity per Package
10
Contains DI Package
20389151000225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 387 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |